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Displaying 661 - 669 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-101006-PIP01-23-M01 (update)
  • IMLIFIDASE
  • Prevention of graft rejection following solid organ transplantation
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Idefirix
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100093-PIP01-21-M03 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis)
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-101000-PIP01-23-M01 (update)
  • Rilzabrutinib
  • Treatment of Immune thrombocytopenia
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100301-PIP05-23
  • Nipocalimab
  • Treatment of Idiopathic inflammatory myopathies
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100203-PIP01-21-M02 (update)
  • Avacopan
  • Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis
  • Tavneos
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-101027-PIP01-23-M01 (update)
  • ANIFROLUMAB
  • Treatment of Systemic Lupus Erythematosus
  • Saphnelo
  • Saphnelo
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100779-PIP01-22-M02 (update)
  • GUSELKUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100689-PIP01-22
  • Dersimelagon
  • Treatment of systemic sclerosis
  • Other: Autoimmune and immune dysfunction diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100471-PIP01-22-M01 (update)
  • SETMELANOTIDE
  • Treatment of appetite and general nutrition disorders
  • IMCIVREE
  • IMCIVREE
  • IMCIVREE
  • IMCIVREE
  • Nutrition
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/02/2023